NCT00000435|CompletedPhase 2
dnaJ Peptide for Relieving Rheumatoid Arthritis
A Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)
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A Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)
Sponsor study identifier
Secondary identifiers
interventional
160
1 country
8
Study Start
September 1999
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
A small protein called dnaJ peptide may help people with rheumatoid arthritis (RA) by preventing their immune system cells from attacking their own tissues. The purpose of this study is to determine if small amounts of dnaJ peptide can "re-educate" immune cells in people with RA so that the cells stop attacking joint tissues.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1999
Date type not reportedThis date has not been verified as actual or estimated.
January 21, 2000
Actual (reported)January 24, 2000
Actual (reported)September 2004
Date type not reportedThis date has not been verified as actual or estimated.
Area under the curve or 'AUC' obtained by adding 0 for no response and 1 for an ACR 20 response for visits on Day 112, 140, and 168
time points 112, 140 and 168 of the 6-month trial
Day 112 ACR 20 score
Visit day 112 of the 6-month trial
Subjects randomized to arm A received 25mg/day po of placebo
Subjects randomized to Arm B received 25mg/day po of peptide dnaJP1
dnaJP1 was taken in pill form at 25mg/day for 6 months
placebo was taken in pill form at 25mg/day for 6 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Arizona Health Sciences Center
Tucson, Arizona, 85724-5093, United States
University of California, Irvine Medical Center
Orange, California, 92868, United States
Stanford University
Palo Alto, California, 94305, United States
Denver Arthritis Center
Denver, Colorado, 80230, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Guthrie Clinic
Sayre, Pennsylvania, 18840, United States
Prakken BJ, Samodal R, Le TD, Giannoni F, Yung GP, Scavulli J, Amox D, Roord S, de Kleer I, Bonnin D, Lanza P, Berry C, Massa M, Billetta R, Albani S. Epitope-specific immunotherapy induces immune deviation of proinflammatory T cells in rheumatoid arthritis. Proc Natl Acad Sci U S A. 2004 Mar 23;101(12):4228-33. doi: 10.1073/pnas.0400061101. Epub 2004 Mar 15.
Koffeman EC, Genovese M, Amox D, Keogh E, Santana E, Matteson EL, Kavanaugh A, Molitor JA, Schiff MH, Posever JO, Bathon JM, Kivitz AJ, Samodal R, Belardi F, Dennehey C, van den Broek T, van Wijk F, Zhang X, Zieseniss P, Le T, Prakken BA, Cutter GC, Albani S. Epitope-specific immunotherapy of rheumatoid arthritis: clinical responsiveness occurs with immune deviation and relies on the expression of a cluster of molecules associated with T cell tolerance in a double-blind, placebo-controlled, pilot phase II trial. Arthritis Rheum. 2009 Nov;60(11):3207-16. doi: 10.1002/art.24916.
Salvatore Albani, MD
University of California, San Diego
160 participants (actual enrollment reported by the registry).
First Submitted
January 21, 2000
First Posted
January 24, 2000
Study Start
September 1999
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.
Contact the study team to confirm eligibility.
Virginia Mason Research Center
Seattle, Washington, 98104, United States
Study Completion
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
July 31, 2007
Record last verified: 2007-07
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Source: ClinicalTrials.gov.
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